Comparative evaluation of the clinical success and periodontal effect of Conventional band and loop, Prefabricated E- space maintainers and Fiber reinforced composite resin space maintainers: A RANDOMIZED CONTROLLED CLINICAL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Clinical success and periodontal health of band and loop space maintainers
研究概览
简要总结
This study is a randomized controlled clinical trial comparing the clinical success and periodontal effects of three types of space maintainers in children aged 4–8 years:
- Conventional band and loop space maintainers
- Prefabricated E-band and loop space maintainers
- Fiber-reinforced composite resin (FRCR) space maintainers
A total of 45 children meeting strict inclusion criteria will be randomly assigned to one of the three groups (15 per group). Each child will receive the allocated appliance after extraction of a primary molar. The plaque index (PI) and gingival index (GI) will be recorded for the banded tooth at 1, 3, and 6 months to evaluate periodontal health, and appliance failures (cement loss, deformation, debonding, etc.) will be documented to assess clinical success.
The study aims to determine whether prefabricated E-band and loop or FRCR space maintainers perform better than conventional designs in terms of survival rate, periodontal health, and patient comfort, based on existing literature suggesting potential advantages like reduced chair time, better aesthetics, and less risk to abutment teeth. Data will be analyzed using Chi-square, repeated measures ANOVA, and independent t-tests.
In essence, the trial seeks evidence to guide pediatric dentists toward the most effective, patient-friendly, and periodontally safe space maintainer option for managing premature primary molar loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 4.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children between the age group of 4-8 years with Frankels behaviour rating score of 1 and 2 2.Systemically healthy children.
- •3.Children with missing maxillary or mandibular primary molars 4.Sound and healthy teeth adjacent to the missing tooth.
- •5.No abnormal dental conditions such as crossbite, open bite, and deep bite.
- •6.Presence of succedaneous tooth bud.
- •7.Presence of at least 1 mm bone overlying the succedaneous tooth germ with less than one-third of the root formed.
排除标准
- •Children with special health care needs.
- •Children with underlying any systemic conditions.
- •Children who are allergic to local anaesthesia or any of the materials used in the study.
- •Grossly carious teeth adjacent to the missing tooth.
结局指标
主要结局
Clinical success and periodontal health of band and loop space maintainers
时间窗: 1,3 and 6 month
次要结局
- To assess and compare the clinical success of Conventional band and loop space maintainers, Prefabricated E- space maintainers and Fiber reinforced band–loop space maintainers at 1,3 and 6 months
研究者
Iccha Upadhyay
SRM Ramapuram